1. Field of Invention
This disclosure relates to medical devices and kits used for diagnostic and screening purposes. More specifically, the disclosure relates to an improved and fully self-contained test unit designed for use in a non-hospital or non-clinic setting to detect bacteria, viruses, or other pathogens, such as strep throat-causing bacteria.
2. Description of Related Art
Medical swabs are often utilized to collect biological specimens for further analysis. Medical swabs can be comprised of an elongated shaft with a fibrous (foam or cotton) tip, or a serrated metal tip to collect culture samples from various areas of infection in question, including the ear, nose, or throat. Sample specimens may interact with chemical reagents to indicate the presence of infection. Commonly, tests performed include enzymatic tests, monoclonal-based tests, fluorescent tests, agglutination tests, and other tests that provide information regarding a tester's condition or presence of bacteria.
Conventional specimen collection often requires that the biological specimen be transferred or transported from a swab to a slide, test tube, or other medical apparatus for contact with chemical reagents. Such transportation of the biological specimens poses risks to the accuracy of test results and analysis. This is because there is often an insufficient amount of the biological sample transferred from the test swab to a slide or test tube. Moreover, during transportation there is the potential that the biological specimen may become contaminated due to multiple people handling the biological sample or from contact with various unsterile surfaces. Further, if the biological sample is not transferred and analyzed in a timely manner, the biological sample may become invalid or dry, thus decreasing the reliability of the test.
Many diagnostic tests may also require special equipment or need to be performed by medical professionals. This can increase the cost and burden on the tester and may reduce the likelihood of early detection.
Needs therefore exist for improved diagnostic tests, and particularly for detection products designed and sold for non-hospital and non-clinic setting such as grocery stores, drug stores, pharmacies, and the home.
3. References of Interest
The following references may be of interest: U.S. Pat. Nos. 8,038,965, 7,098,040, 6,524,530, 6,248,294, 6,180,395, 5,965,453, 5,879,635, 5,869,003, 5,827,675; U.S. Publication No. 2008/0260581, 2012/0082977; PCT Publication No. WO2010/129726; European Patent Publication No. EP1714133A1, EP1697717A1, EP1338338A1, EP1024354A1, EP0981729B1, EP0861330B1.